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FDA Weighs Pros, Cons of Home Genetic Testing
Date:3/8/2011

ffect people who receive disturbing results.

Consumers can take a sample of their saliva or blood, for example, and send it to a clinical laboratory for analysis without guidance or oversight from a medical professional. Patients must initiate any medical follow-up or counseling on their own.

Because people might make medical decisions based on the test results, the FDA will likely set standards to minimize the chance of misuse or misinterpretation of test results, similar to standards governing prescription-only genetic tests or home tests such as pregnancy tests.

Other considerations will include how to categorize the different types of home genetic tests. Three possibilities, the FDA said, include: tests that screen for carriers of a heritable disorder; tests that predict risk for a disorder such as ovarian cancer in people with no symptoms; and tests claiming to predict how someone will respond to a particular drug or medical treatment.

While test makers are expected to defend their products, test accuracy is a key concern of skeptical medical professionals. A recent undercover study of 15 direct-to-consumer genetic tests by the U.S. Government Accountability Office found "egregious examples of deceptive marketing, in addition to poor or nonexistent advice from supposed consultation experts." That report was published in The Lancet.

Whether the test results are clinically valid or clinically useful is also a concern. Dr. Bruce R. Korf, president of the American College of Medical Genetics, recently told HealthDay that inaccurate results could create a sense of "false reassurance."

Someone who learns he or she is at reduced risk for type 2 diabetes, for example, might figure they don't need to worry about weight or diet, said Korf, who is also chair of genetics at the University of Alabama at Birmingham. "The [test] may not give you the whole story and may not even be true for [that patient]," he said.

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